What Does Non-Formulary Mean?
Non-formulary refers to medications that are not included on a healthcare facility's or insurance plan's approved list of routinely stocked drugs, typically excluded due to high cost, insufficient clinical evidence, or availability of preferred therapeutic alternatives. 1, 2
Core Definition and Context
A formulary is a continually updated list of medications deemed effective, safe, and cost-saving that are routinely stocked by hospitals and healthcare facilities. 2 Non-formulary drugs (NFDs) fall outside this approved list and require special procedures to obtain. 2, 3
Key Characteristics of Non-Formulary Medications
Previously evaluated and denied: Approximately 65% of non-formulary requests involve drugs that the pharmacy and therapeutics committee has already reviewed and declined to add to the formulary. 3
Cost implications: When formulary alternatives exist, using non-formulary products results in measurable cost increases, with studies showing potential savings of nearly $2,000 when formulary alternatives are substituted. 3
Access barriers: Non-formulary medications often face procurement delays and lengthy processing times, with 35.5% of requests taking 2-4 months from initial order to medication receipt, and 8.6% exceeding six months. 2
Clinical Impact and Practical Considerations
Effects on Patient Care
Non-formulary restrictions can create significant clinical challenges:
Treatment delays: 40.3% of healthcare providers report delays in patient care due to formulary restrictions. 2
Suboptimal therapy: 33.8% of clinicians are forced to use less effective formulary alternatives when non-formulary drugs are unavailable. 2
Compromised outcomes: 26.9% of providers agree that formulary restrictions hinder medical care delivery. 2
The Request Process
When clinicians need non-formulary medications, they must navigate approval procedures:
Processing time: 31.2% of requests receive decisions within one week, while 28% take two weeks to one month. 2
Approval rates: In most institutional settings, the majority of non-formulary requests are ultimately approved (99% in one study), though the process creates delays. 4
Documentation requirements: Requests typically require clinical justification, including indication for use, supporting evidence, and proposed monitoring outcomes. 4
Common Pitfalls and Misunderstandings
Prescribing Errors
Non-formulary orders frequently contain mistakes:
Error rate: 28% of all orders entered as non-formulary contain prescribing errors. 5
Common errors: 49% involve incorrect dosages and 33% are misspelled medication names. 5
Misclassification: 30% of orders entered as "non-formulary" are actually formulary medications, indicating confusion about formulary status. 5
Cost Considerations for Patients
The distinction between formulary and non-formulary status directly affects patient out-of-pocket costs:
Insurance tier placement: Non-formulary medications are often placed on higher cost-sharing tiers, resulting in substantially higher copayments for patients. 1
Prior authorization requirements: 27% of non-formulary medications require prior authorization before insurance coverage, adding administrative burden and potential delays. 1
Variable coverage: Formulary decisions vary between insurance plans, meaning a medication may be formulary under one plan but non-formulary under another. 1
Special Contexts
High-Cost Medications
Non-formulary status is particularly common for expensive therapies:
Threshold: Medications costing more than $5,000 per year frequently require individual patient use applications even when clinically indicated. 4
Evidence requirements: 40% of high-cost non-formulary requests are supported only by case series rather than randomized controlled trials. 4
Biosimilars and Alternatives
Drug formularies may exclude certain agents when alternatives exist:
Regulatory approval: Zoledronic acid was added to some formularies for adjuvant breast cancer treatment only after specific approval for that indication, despite being available for other uses. 1
Geographic variation: Medication availability varies by region, with some agents approved in one country but unavailable in another (e.g., clodronate availability differs between Canada and the United States). 1